Source Job

• Oversight of site level tasks associated with efficient site activation.
• Support the CRA team in preparing for site initiation visits (SIVs).
• Perform initial contract and budget negotiations with the sites, as well as amended where applicable

Fortrea helps to turn the impossible into I'm possible. They deliver exceptional service to their patients, fueled by a shared commitment to teamwork and excellence.

• Lead and oversee end-to-end clinical trial operations from study start-up through close-out.
• Develop and execute operational plans, timelines, and performance metrics to support successful delivery of assigned studies.
• Proactively identify operational risks and implement mitigation strategies to maintain timelines, quality, and compliance.

Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision-making led by subject matter experts. Their asset-centric model offers a unique R&D logic that has been applied by single-asset companies to improve productivity.

• Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management.
• Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
• Identify risks and propose solutions to facilitate clinical studies.

Nuvalent is working to create selective medicines designed to address the needs of patients with cancer. They are an exciting early-stage company with experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

• Leads the Clinical Study Team for assigned projects from concept to protocol.
• Manages external vendors and contract research organizations.
• Manages operational activities at the study level and monitoring activities at clinical study sites to assure adherence to GCP, SOPs, and study protocols.

BridgeBio is committed to discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases with unmet needs. They build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

• Responsible for delivery of site activation readiness within the assigned country/sites.
• Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points.

Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

• Manage site start up through activation readiness strategy and oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning and alignment of operational goals.

Precision for Medicine is a Clinical Research Organization with an integrated offering that enables precision medicine by combining clinical trial designs, experts, biomarker and data analytics solutions. They focus on rare diseases and oncology, in addition to other therapeutic areas.

• Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits.
• Oversee the execution of Site Activation, site activation strategy, adhering to project timelines.
• Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent.

Care Access is dedicated to making the future of health better for all by bringing world-class research and health services directly to communities. With hundreds of research locations, mobile clinics, and clinicians across the globe, they focus on ensuring every person has the opportunity to understand their health and access the care they need.

• Leads the cross-functional Trial Team (CTT); tracking of project deliverables & timelines.
• Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs)
• Accountable for the delivery of the trial within agreed/projected life of trial budget.

Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint and searching for high-impact individuals.

• Oversee a portfolio of 3-5 active trials, supporting Project Leads to ensure trial success.
• Manage commercial matters within agreed SOW parameters, own sponsor account relationships, and play a pivotal role.
• Line manage 3-5 Project Leads and Project Associates, providing performance reviews and professional development.

Lindus Health is powering biology's century with faster, more reliable clinical trials. They are transforming how people think about developing new treatments, so patients can access breakthrough treatments faster; Lindus Health has powered 100+ clinical trials involving tens of thousands of patients.

• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
• Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
• Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.

Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.

• Perform discovery visits to access sites for research partnerships.
• Provide protocol and product/procedural training to clinical sites.
• Assist sites with pre-screening patients to ensure appropriateness for clinical study, as applicable.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our 114,000 colleagues serve people in more than 160 countries, providing a portfolio of life-changing technologies across the spectrum of healthcare.

• Assist in design, author and/or review clinical study synopses, protocols, study reports and other study-related documents.
• Act as a medical monitor for assigned study and discuss study design with investigators and key opinion leaders.
• Track emerging efficacy and safety profile of drugs in clinical trials; inform Clinical Development team of changes in the efficacy/safety profiles.

Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer patients. The company aims to improve cancer treatment by targeting cellular drivers of tumor growth and is publicly traded.

• Serves as the clinical trial lead responsible for the planning, conduct and oversight of clinical studies.
• Develop study related clinical documents and generate potential site list from key stakeholders.
• Manage processes for investigational product including drug accountability and reconciliation.

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the speed, cost and success rate of bringing therapies to patients. They focus on Oncology and Rare Disease, providing deep scientific knowledge.

• Ensure compliance with standard protocol and regulatory and ICH GCP obligations.
• Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan.
• Write and submit reports of investigational site findings and update applicable tracking systems.

Freenome is dedicated to changing the entire landscape of cancer. Freenome is an equal opportunity employer and values diversity.

• Provide medical expertise and leadership in clinical development strategies aligned with company objectives.
• Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements.
• Serve as medical monitor for clinical trials and ensure adherence to ICH GCP, patient safety, and data integrity.

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. With nearly 100 years of experience and global hubs in the U.S., France, and the U.K, they are committed to a culture of collaboration, excellence, and impact and empower every individual to be their true selves and grow alongside the company’s success.

• Responsible for timely and quality delivery of site activation readiness, mitigating risks.
• Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
• Maintain project plans, trackers, and regulatory intelligence tools.

Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.

• Considered as the primary point of contact for the investigative site and strengthens AbbVie’s positioning.
• Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision.
• Develop solid knowledge of therapeutic area, asset and clinical landscape to enable successful patient recruitment.

AbbVie discovers and delivers innovative medicines and solutions that solve serious health issues. They strive to have a remarkable impact on people's lives across several key therapeutic areas.

• Lead the planning/execution of clinical studies, aligning with regulatory/business objectives.
• Manage relationships with CROs, vendors, and external partners for timely/cost-effective study delivery.
• Project manage clinical trials, overseeing timelines, budgets, and deliverables.

Jobgether is a platform that helps connect job seekers with companies. They use AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly against the role's core requirements.

• Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
• Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
• Develop and implement inspection readiness plans and procedures for Health Authority inspections.

Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.

• Set submission strategy and operational timelines.
• Build, evolve, and manage the Regulatory Operations infrastructure.
• Establish and oversee training on RA procedures and submission standards.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.